Actively Recruiting
18F-mFBG Cardiac Uptake With Lewy Body Dementia
Led by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.
CONDITIONS
Official Title
18F-mFBG Cardiac Uptake With Lewy Body Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at study entry
- Able and willing to follow study procedures and provide signed informed consent
- Female participants must be surgically sterile, postmenopausal, non-lactating, or have a negative pregnancy test if of childbearing potential
- Clinically stable for at least 30 days before enrollment and remain stable until imaging
- For Lewy body disease group: diagnosed with Parkinson's disease or Lewy body dementia at least 6 months before enrollment
- For non-Lewy body disease group: diagnosed with neurological or neurodegenerative disease not likely to be Parkinson's disease or Lewy body dementia as judged by a neurologist
You will not qualify if you...
- Previously participated in this study or another investigational study within 30 days before enrollment
- History or suspicion of severe allergic reaction to components of 18F-mFBG
- Any serious, life-threatening disease with less than 1 year life expectancy or that compromises study participation
- Diagnosed ischemic heart disease or heart failure of any cause
- Serious non-cardiac conditions with high plasma catecholamines including pheochromocytoma
- Claustrophobia or movement disorder preventing lying still for up to 20 minutes
- Renal insufficiency with serum creatinine above 3.0 mg/dL
- Use of medications interfering with NET-dependent agent uptake that cannot be withheld safely 24 hours before imaging
- Participation in radiation research studies in the past 12 months risking total radiation dose over 50 milliSieverts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Research Coordinator
CONTACT
C
Clinical Trials Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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